Colonic Polyp
Conditions
Brief summary
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.
Interventions
DEVICEGI Genius CADx device
GI Genius System is an Intelligent Endoscopy Module designed to be an adjunct to video colonoscopy with the purpose of supporting the operating physician with artificial intelligence during colonoscopy. GI Genius CADx is the AI software that provides a histology prediction of framed polyps during real-time colonoscopy, with each polyp being classified as adenoma or non-adenoma.
Sponsors
Nuovo Regina Margherita Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 40 years or older undergoing screening colonoscopy for CRC * Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation
Exclusion criteria
* subjects at high risk for colorectal cancer * subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes * patients with previous resection of the sigmoid rectum * patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings * patients who perform an emergency colonoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Predictive Value (NPV) | 4 months | Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-polypectomy surveillance interval | 4 months | Agreement in assignment of post-polypectomy surveillance intervals of the enrolled patients according to established guidelines between the combined use of GI Genius CADx as optical diagnosis for diminutive (≤5 mm) polyps and conventional histology as diagnostic tool for polyps \> 5 mm, and histology as diagnostic tool for all the resected polyps (regardless of size or location) |
| Performance metrics of GI Genius CADx | 4 months | Sensitivity, Specificity, Accuracy, PPV and NPV of GI Genius CADx optical diagnosis |
| Performance metrics of the endoscopist with the aid of GI Genius CADx | 4 months | Sensitivity, Specificity, Accuracy, PPV and NPV of the optical diagnosis of endoscopists assessing lesions in white-light with the help of GI Genius CADx. |
Countries
Italy
Outcome results
None listed